| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02956837 | A Study to Rank Different Dosages of Antigen of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A), Based on Their Immune Response and Safety, When Administered to Healthy Adult Women | PHASE2 | COMPLETED | 406 | — | — | Nov 10, 2016 | Feb 5, 2018 | Jul 2, 2019 | 8 | Belgium, Estonia +2 |
Assessed solicited general AEs were fatigue, gastrointestinal symptoms \[nausea, vomiting, diarrhea and/or abdominal pain\], fever and headache. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.Grade 2 symptoms = occurrence of symptoms discomforting enough to interfere with daily activities. Grade 3 symptoms = symptoms that prevented normal activities. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
Grade 2 Fever was defined as oral temperature above (\>) 38.5 degrees Celsius (°C) to less than or equal to (≤) 39.5°C. Grade 3 Fever was defined as oral temperature \> 39.5°C. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAEs = SAEs assessed by the investigator as related to the vaccination. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
RSV-A is one of the two antigenically distinct subgroups of the Respiratory Synctial Virus (RSV). Antibody titers were determined by neutralization assay and presented as geometric mean titers (GMTs), for a seropositivity cut-off value greater than or equal to (≥) 8 ED60 (Estimated Dilution 60). This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
PCA concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL), for a seropositivity cut-off ≥ 9.6 µg/mL. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
PCA concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL), for a seropositivity cut-off ≥ 9.6 µg/mL. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
| Arm | Type | Description |
|---|---|---|
| GSK3003891A vaccine formulation 1 Group | EXPERIMENTAL | Subjects in this group received a single 30 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0. |
| GSK3003891A vaccine formulation 2 Group | EXPERIMENTAL | Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. |
| GSK3003891A vaccine formulation 3 Group | EXPERIMENTAL | Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. |
| Control Group | PLACEBO_COMPARATOR | Subjects in this group received a single placebo injection at Day 0. |
| Name | Type | Description |
|---|---|---|
| RSV Vaccine (GSK3003891A) formulation 1 | BIOLOGICAL | Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm. |
| RSV Vaccine (GSK3003891A) formulation 2 | BIOLOGICAL | Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm. |
| RSV Vaccine (GSK3003891A) formulation 3 | BIOLOGICAL | Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm. |
| Placebo (Formulation buffer S9b) | DRUG | A single dose of placebo is administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm. |
Inclusion Criteria: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject prior to performance of any study specific procedure. * Non-pregnant female between, and including, 18 and 45 years...